Ex Parte B. Santos et al - Page 6


                 Appeal No.  2006-0251                                                           Page 6                   
                 Application No.  10/017,697                                                                              
                 masked liquid pharmaceutical composition.  Compare, appellants’ disclosure                               
                 (specification, page 4), “[i]n the present invention, the normally bitter drug is                        
                 dissolved or dispersed in an aqueous taste masking excipient base comprising a                           
                 polyvinyl pyrrolidone and/or copolyvidone, and a high MW polyethylene glycol.                            
                 The taste masked liquid composition has substantially reduced bitter taste and                           
                 aftertaste.”  According to the examiner (Answer, page 10), “[i]f polyethylene                            
                 glycol and polyvinylpyrrolidone are taste-masking agents in the instant case, the                        
                 polyethylene glycol and polyvinylpyrrolidone will also mask the taste of the bitter                      
                 or unpleasant tasting drug [in White].”                                                                  
                         Based on the foregoing analysis, we find the examiner provided the                               
                 evidence necessary to establish a prima facie case of anticipation based on                              
                 inherency.  Accordingly, the burden shifts to appellants to “prove that the subject                      
                 matter shown to be in the prior art does not possess the characteristic relied on.”                      
                 In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 229 (CCPA 1971).                                    
                 Accord In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980),                                 
                 quoted with approval in In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966                               
                 (Fed.Cir.1985); In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA                              
                 1977); In re Ludtke, 441 F.2d 660, 664, 169 USPQ 563, 566 (1971).                                        
                         According to appellants (Brief, page 6), a tri-ester is an essential                             
                 component of White’s composition.  In this regard, appellants point out (id.) that                       
                 tri-esters have a bitter taste.  Accord White, column 3, lines 22-23, “[t]ri-esters                      
                 are generally clear, viscous liquids with a bitter taste and low toxicity.”  Thus,                       
                 appellants assert (Brief, page 6), “the compositions disclosed by White contain                          







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